Biosimilars (BS) are promoted worldwide because of the high cost of biologics. However, patients are apprehensive about switching to BS. For some diseases, several factors, which may be disease-dependent, influence patients' acceptance of switching to BS. Herein, we evaluated whether factors influencing acceptance for switching were disease-dependent among Japanese patients with different diseases. This crosssectional study involved pharmacists' interviews with patients who used or planned to use biologics. Demographic and clinical characteristics were retrospectively investigated using the patients' medical records. Multivariate logistic regression showed that switch refusal was associated with a history of adverse reactions to biologics (odds ratio [95% confidence interval (CI)] 3.38 [1.35-8.44]), history of complaints related to disease activity (3.57 [1.53-8.32]), and unacceptability of generic drugs (7.62 [2.70-21.60]). Subgroup analyses suggested that the unacceptability of generic drugs was a common factor, regardless of the disease. Concomitantly, histories of adverse reactions to biologics and complaints related to disease activity were disease-dependent factors. Healthcare professionals should help patients in selecting BS, considering these factors according to the disease.
Daratumumab (DARA) is a treatment for relapsed or refractory multiple myeloma. The MMY 3003 trial compared DARA, lenalidomide, and dexamethasone combination therapy (DLd therapy) with lenalidomide and dexamethasone combination therapy (Ld therapy). There were 283 cases in which DARA is included in the group, among which there are only 20 cases in Japan, with limited information on ef cacy and safety in the Japanese population. Another characteristic of DARA adverse events is the Infusion Related Reaction (IRR). The risk factors associated with DARA s IRR have not been identi ed yet, and there are concerns about their impact on treatment.Therefore, we retrospectively examined the safety of DARA in Japanese patients who received DARA and investigated the risk factors for IRR expression in multiple myeloma patients at our hospital. With regard to adverse events, we have experienced cases in which hematologic toxicity is Grade 3 or higher, but in non-hematologic toxicity, no case has resulted in serious outcomes of Grade 3 or higher. Any adverse event that occurred during the survey period could be managed with coping therapy, and safety was secured when DARA was administered. Although IRR has frequently occurred in DARA administration, there have been no reports on the risk factors for IRR expression to date. However, in this study, cases with IMiDs refractory as a risk factor for IRR were signi cantly affected. It is shown that IMiDs refractory cases can cope with IRR earlier by responding to risk factors.
In this study, we conducted cost-effectiveness analysis, with a focus on situations in which plerixafor was administered from day four after starting administration of the G-CSF preparation or in which plerixafor administration was determined based on the CD34 + cell count. We retrospectively reviewed the medical records of patients with malignant lymphoma or multiple myeloma, who underwent autologous peripheral blood stem cell collection in this hospital between March 2017 and April 2018. Decision tree algorithms were used to analyze cost-effectiveness.The expected cost of collecting CD34 + cells (2 10 6 cells/kg) within two days of apheresis was approximately JPY1.2 million, when plerixafor was administered from day four regardless of the CD34 + cell count. However, the expected cost of that was approximately JPY1 million, when plerixafor administration was determined based on the CD34 + cell count. Furthermore, even when the parameters affecting the expected cost, such as the drug price of plerixafor, were changed, the expected cost of collecting the CD34 + cells when plerixafor administration was determined based on the CD34 + cell count was lower than that when plerixafor was administered regardless of the CD34 + cell count.
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